Preeti Saini

Expert in Regulatory Compliance & Market Research for Medical Devices

Richmond Hill, Ontario, Canada

Skills

Scientific Research, Laboratory Techniques, Medical Writing, Respiratory Devices, Urological Devices, Scientific Data Interpretation, Technical Writing, Publications, Clinical Evaluation Reports, Regulatory Guidelines (MEDDEV2.7/1 rev 5, ICH, Health Canada, FDA), Risk Mitigation, Corrective and Preventive Actions (CAPA), Graduate Level Teaching, Conference Organization, Global Communication, Microbiology Laboratory Equipment, Method Validation / Verification, Bioanalytical Techniques, Aseptic Techniques, Data Analysis, Biochemical Analysis, Media Preparation, Phytochemical Analysis, Biological Activity Testing, Sample Processing, Extraction and Purification, Microscopic Examination, Molecular Biology Techniques, Quality Assurance (QA), Clinical Trials, Audits, Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Laboratory Information Management System (LIMS), Statistical Software (SPSS, Prism – GraphPad), Reference Management Software (EndNote, Citavi, Mendeley, Zotero), Social Media Platforms (LinkedIn, Skype, WhatsApp, Facebook, Instagram, Zoom, Microsoft Teams), Presentation Skills, Multilingual Communication (English, Hindi, Punjabi), French (Beginner), Problem-solving, Leadership, Team Collaboration, Time Management, Administrative Skills, Customer Service, Analytical Thinking, Trustworthiness

About

I am a versatile professional with a robust background in medical writing, academic support, and microbiological research. As a Specialist Medical Writer at Tata Elxsi Ltd. from 2019 to 2021, I crafted seven Clinical Evaluation Report (CER) packages, ensuring global regulatory compliance and enhancing efficiency through meticulous data analysis and proactive literature reviews. Prior to this, as an Academic Support Specialist at BioTecNika Info. Labs Pvt. Ltd. (2017 – 2019), I led teams, developed innovative courses reaching over 1000 students, and organized international conferences. My Ph.D. in Microbiology from Punjab Agricultural University (2013 – 2016) involved pioneering research on bioactive metabolites from endophytic actinomycetes, contributing significantly to natural product research. Throughout my career, I have demonstrated a commitment to scientific excellence, regulatory adherence, and educational advancement, driven by continuous learning and professional development.